FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660022426
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
House stapes curette
Catalog number
19-580
Device description
House stapes curette, 6'', double-ended, strongly angled, 2.0mm x 2.5mm and 2.25mm x 3.0mm cups, flat handle
Published
2021-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYGCURETTE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660022426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660022426001906600224261906600224260190660022426

GMDN Terms#

Term, Definition table
TermDefinition
Endaural curette, reusableA slender, hand-held, manual surgical instrument designed for scraping within the ear canal (e.g., removing wax), and during middle ear surgery (e.g., removal of the superior bony rim). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags#

DUNS number
015272206
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660083373Ambler SurgicalAmbler ingrown tissue hook37-1292021-01-07
00190660086343Ambler SurgicalR-Style nerve hook37-8252021-01-07
00190660086350Ambler SurgicalR-Style nerve hook37-8272021-01-07
00190660086367Ambler SurgicalR-Style nerve hook37-8262021-01-07
00190660086374Ambler SurgicalR-Style nerve hook37-8282021-01-07
00190660086381Ambler SurgicalYasargil micro hook37-8722021-01-07
00190660086398Ambler SurgicalYasargil micro hook37-8702021-01-07
00190660121549Ambler SurgicalR-Style needle57-4262021-01-07
00190660121556Ambler SurgicalR-Style needle57-4282021-01-07
00190660141578Ambler SurgicalSalinger reduction instrument73-1252021-01-07
00190660100360Ambler SurgicalFiberoptic light cable40-8002021-01-04
00190660100377Ambler SurgicalFiberoptic light cable40-5002021-01-04
00190660100384Ambler SurgicalFiberoptic light cable40-8102021-01-04
00190660100391Ambler SurgicalFiberoptic light cable40-5052021-01-04
00190660100407Ambler SurgicalFiberoptic light cable40-8202021-01-04
00190660100414Ambler SurgicalFiberoptic light cable40-8302021-01-04
00190660100421Ambler SurgicalFiberoptic light cable40-5102021-01-04
00190660100438Ambler SurgicalFiberoptic light cable40-5152021-01-04
00190660100445Ambler SurgicalFiberoptic light cable40-5202021-01-04
00190660100452Ambler SurgicalFiberoptic light cable40-5252021-01-04

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Primary DI, Brand, Company table
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00724995271633V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271640V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271657V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995271800V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995273958V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
00724995273965V. MuellerSTERIS Deutschland GmbHJYG2026-09-25
04054462901630evonosevonos GmbH & Co. KGJYG2026-08-21
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04054462901678evonosevonos GmbH & Co. KGJYG2026-08-18
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00190776422295MillenniumAvalign Technologies, Inc.JYG2026-07-31
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00190776422394MillenniumAvalign Technologies, Inc.JYG2026-07-31
09348811100542INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-07-31